The attention of the Agency has been drawn to the alert by FDA regarding compounded or repackaged drugs stored in Becton-Dickson (BD) general use syringes, 1ml, 3ml, 5ml, 10ml, 20ml and 30ml syringes. The alert was based on Becton-Dickson reports that an interaction on the rubber stopper in certain lots of these syringes can cause some drugs stored in these syringes to lose potency if filled and not used immediately. These syringes have been cleared as medical devices for general purpose fluid aspiration and injection only and not for use as closed container storage system for drug products as the suitability of these syringes for that purpose have not been established.

The drugs that have been reported by Becton-Dickson to be affected by the stoppers include fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone, atropine, hydromorphone, cisatracurium and remifetanyl.

Action required from Prescriber/Patients

Healthcare providers, hospital and pharmacy staff should check supply stocks and remove drug products that were filled by pharmacies or outsourcing facilities and stored in these general purpose BD syringes.

Do not administer compounded or repackaged drugs that have been stored in any of these syringes unless there is no suitable alternative available.

Notify NAFDAC immediately of any issues arising from the use of drugs already stored in these syringes for further necessary actions.